Essential Duties and Responsibilities
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
- Develop, implement, and continuously enhance site or enterprise validation strategies aligned with regulatory expectations and business objectives.
- Lead lifecycle validation programs to sustain the qualified and validated state of facilities, utilities, systems, equipment, and manufacturing processes.
- Establish and maintain Validation Master Plans (VMPs), validation policies, and governance frameworks.
- Drive the adoption of risk-based validation methodologies grounded in scientific and quality risk management principles.
- Champion continuous improvement initiatives to enhance compliance, operational efficiency, reliability, and inspection readiness.
- Ensure validation strategies support commercial manufacturing continuity, new product introductions, and organizational growth.
- Provide leadership and oversight across validation disciplines, including equipment qualification (DQ, IQ, OQ, PQ), process validation and continued process verification (CPV), cleaning validation, contamination control strategies, facility and utility qualification, HVAC systems, computerized system validation (CSV), packaging and labeling validation, environmental monitoring, aseptic process validation, and CQV activities.
- Review and approve validation protocols, reports, acceptance criteria, and technical justifications.
- Ensure timely execution of validation deliverables in alignment with operational priorities and capital projects.
- Oversee deviations, investigations, change control processes, risk assessments, and remediation activities related to validation systems.
- Ensure data integrity standards and documentation practices are compliant with current cGMP expectations.
- Ensure compliance with global cGMP regulations, regulatory agency expectations, and industry guidance.
- Lead validation readiness efforts for regulatory inspections, customer audits, and internal assessments.
- Serve as subject matter expert (SME) during inspections and audit engagements.
- Partner with Quality and Compliance teams to address CAPAs, deviations, audit observations, and remediation plans.
- Ensure validation activities align with data integrity requirements and quality risk management principles.
- Lead, coach, and develop validation managers, engineers, specialists, and technical staff.
- Establish departmental goals, performance metrics, staffing plans, and succession strategies.
- Manage departmental budgets, contractor resources, and prioritization of validation activities.
- Foster a high-performance culture emphasizing accountability, collaboration, technical excellence, and compliance.
- Collaborate cross-functionally with Manufacturing, Engineering, Quality, Regulatory, Automation, Supply Chain, and Project Management teams to support new product introductions, technology transfers, facility expansions, startup activities, capital projects, process optimization, continuous improvement, and product lifecycle management.
- Provide validation expertise and guidance during deviations, investigations, change management, risk assessments, and remediation programs.
- Establish and maintain validation governance frameworks to ensure consistency in validation standards, methodologies, and lifecycle execution.
- Lead validation review boards, governance forums, and escalation pathways as appropriate.
- Ensure alignment of validation practices across departments and, where applicable, enterprise operations.
- Perform any other tasks/duties as assigned by management.
Education Requirements and Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.
- Bachelors’ Degree in Life Science, Engineering, or a related field required.
- Minimum 8 years performing Validation Activities in Pharmaceutical or related industry required.
- Minimum 5 -8 years management experience required.
- Strong knowledge of cGMP regulations and practices pertaining to validation principals, aseptic manufacturing processes, automated process control and monitoring systems, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends.
- Experience with Annex 1 contamination control strategies, data integrity programs, major capital expansion projects, technology transfers and regulatory/ inspection remediation efforts preferred
- Experience supporting sterile manufacturing, aseptic processing, biologics, cytotoxic products, or lyophilization operations, preferred
- Strong knowledge of MS-Office software and PC Skills required.
- Good technical writing skills.
- Excellent communication, problem-solving, planning and organization skills.
- Ability to work independently with little supervision.
- Ability to function within a structured team environment.
- Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.
- Ability to work off hours and weekends as needed.
Physical Environment and Requirements
- Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
- Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.
Employee must be able to occasionally lift and/or move up to 50 pounds.
American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.
Applicants have rights under Federal Employment Laws.
Alert: We’re aware of individuals impersonating our staff to target job seekers. Please note:
·All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.
·Our recruiting process includes multiple in person and/or video interviews and assessments.
·If you are unsure about the legitimacy of a message, contact John Rossini at jrossini@americanregent.com before responding.
·We never request payment, bank information, or personal financial details during our offer process.
Your security is important to us, and we encourage you to stay vigilant when job searching.
American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.
